| CTRI Number |
CTRI/2024/07/070777 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the burden and perceived social support of caregivers of alcoholics |
|
Scientific Title of Study
|
A study on burden and perceived social support among caregivers of patients with alcohol dependence syndrome in a tertiary care hospital at Mangaluru |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lalbiakhliri |
| Designation |
1st MSc Nursing Student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Department of Mental Health Nursing, Father Muller College of Nursing Kankanady, Dakshina Kannada, Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9845494067 |
| Fax |
|
| Email |
srveronicalb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lucy P Solo |
| Designation |
1st MSc Nursing Student |
| Affiliation |
Father Muller College of Nursing, Kankanady Mangalore |
| Address |
Department of Mental Health Nursing, Father Muller College of Nursing Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9089447989 |
| Fax |
|
| Email |
sololucy720@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Lavina Rodrigues |
| Designation |
Associate Professor |
| Affiliation |
Father Muller College of Nursing, Kankanady Mangalore |
| Address |
Department of Mental Health Nursing, Father Muller College of Nursing Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9008884848 |
| Fax |
|
| Email |
lavinasyril@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller College of Nursing, Kankanady, Mangaluru,Dakshina Kannada Dist PIN- 575002
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Lalbiakhliri |
| Address |
Father Muller College of Nursing, Kankanady Mangalore
Dakshina Kanada, Pin Code 575002
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Lucy P Solo |
Father Muller College of Nursing, Kankanady Mangalore |
| Preetha Sonia D Souza |
Father Muller College of Nursing, Kankanady Mangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lavina Rodrigues |
Father Muller Medical College Hospital |
Department of Psychiatry, Room no 42, Mangalore
Dakshina Kannada
KARNATAKA |
9008884848
lavinasyril@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The caregivers of patient with alcohol dependence syndrome Who are in the age group of 18 and above.
• Who can speak English and Kannada.
• Care givers of patients with alcohol dependent
syndrome giving care for more than 6 months.
|
|
| ExclusionCriteria |
| Details |
Caregiver who have any major physical/psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| significant correlation between burden and perceived social support among the caregivers of patients with alcohol dependence syndrome. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the burden of alcoholism in the society & also to provide adequate social support to the caregivers of patients with alcoholism |
1 year |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aimed to assess the burden and
perceived social support among caregivers of patients with alcohol dependence
syndrome in a tertiary care hospital at Mangaluru. The sample consists of 120 caregivers of
patients with alcohol dependence syndrome with the age group of above 18years
will be selected using convenient sampling technique. The investigators will obtain the formal written
consent from all the participants.
Burden and perceived social support among caregivers of patients with
alcohol dependence syndrome will be assessed by using baseline profoma, Zarit
Caregiver Burden Assessment (Revised, 22-items) and Multidimensional
Scale of Perceived Social Support. The collected data will be analysed using
descriptive and inferential statistics.
|